Biodesix Oral Presentation At SITC: Testing Methodology May Identify Primary Immunotherapy Resistance In Patients

Preliminary Data Indicate Primary Resistance May Be Overcome by Combination Therapies

Boulder, Colorado, November 7, 2017… Biodesix^® chief technology officer, Dr. Heinrich Roder, will give an oral presentation discussing a proprietary test development methodology that uses machine learning to correlate MALDI-ToF mass spectra from patient pre-treatment serum with clinical outcomes and benefit from therapy, specifically immunotherapies. The presentation will highlight the importance of evaluating the circulating proteome for predicting response to checkpoint inhibition and HD-IL2 therapy. Dr. Roder will also discuss the immune phenotype, known as primary immune resistance, that identifies patients who may obtain little long-term benefit from single agent anti-PD1, anti-CTLA4, or HD-IL2 treatment and who may obtain benefit from additional treatment with combinations of immunotherapies.

“Not all patients respond to immunotherapies,” said Dr. Heinrich Roder. “The pre-treatment circulating proteome contains information that can predict durable benefit from immunotherapies. Our test development platform, an established methodology, can be used to design proteomic tests that answer important clinical questions regarding prognosis, patient selection, treatment monitoring, and drug target discovery related to the use of immunotherapies and other therapies for oncology.”

In addition, the company is presenting two posters on tests created using the methodology described in Dr. Roder’s oral presentation. In the first study, “Proteomic biomarker analysis of metastatic melanoma patients treated with anti-PD-1 checkpoint blockade,” a pre-treatment test associated with acute phase reactants, wound healing and complement activation was shown to successfully stratify melanoma patients into groups with better and worse progression-free and overall survival. The second study, “Mass spectrometry-based test predicts outcome on anti-PD-1 therapy for patients with advanced non-small cell lung cancer,” describes an extension of Biodesix’s melanoma program to non-small cell lung cancer (NSCLC), using a test to identify patients with advanced NSCLC who were likely to have better or worse survival on  anti-PD-1 therapy. It also showed promise in a blinded validation cohort of patients with brain metastases.

The posters and the oral presentation, titled “Biomarkers for primary immunotherapy resistance based on the circulating proteome,” will be part of the program of the 32^nd annual meeting of the Society for the Immunotherapy of Cancer, in National Harbor, MD.

Oral Presentation: “Biomarkers for primary immunotherapy resistance based on the circulating proteome”

Speaker: Heinrich Roder, D.Phil

Date/Time: Wednesday, November 8, 9:40AM EST

Poster: “Proteomic biomarker analysis of metastatic melanoma patients treated with anti-PD-1 checkpoint blockade.”

Presenter: PA Ascierto

Authors: PA Ascierto, M Capone, AM Grimaldi, D Mallardo, E Simeone, H Roder, K Meyer, S Asmellash, C Oliveira, J Roder

Date/Time: Friday, November 10, 12:30-2:00PM; 6:30-8:00PM EST.

Poster:  “Mass spectrometry-based test predicts outcome on anti-PD-1 therapy for patients with advanced non-small cell lung cancer, including those with brain metastases.”

Presenter: Sarah Goldberg

Authors: Sarah B. Goldberg, Lucia Jilaveanu, Harriet M. Kluger,  Veronica Chiang, Amit Mahajan, Bing Xia, Matthew Ribeiro, Heinrich Roder,  Joanna Roder, Carlos Oliveira, Julia Grigorieva, Mirte Muller, Anna-Larissa Niemeijer,  Adrianus de Langen, Robert Schouten, Egbert Smit

Date/Time: Friday, November 10, 12:30-2:00PM; 6:30-8:00PM EST.

About Biodesix

Biodesix^® is a molecular diagnostics company advancing the development of innovative, multi-omic blood tests in oncology to enable precision medicine. Biodesix discovers, develops and commercializes multivariate protein and genomic liquid biopsy tests, including the GeneStrat^® and VeriStrat^® tests, that deliver results within 72 hours. The company is changing the standard of care by providing physicians with diagnostic tests and with the Biodesix Lung Reflex™ testing strategy, for better therapeutic guidance, more accurate prognosis and enhanced disease monitoring to improve patient outcomes. At the forefront of personalized medicine, Biodesix is developing new tests to identify patients who may benefit from immunotherapies. In addition to developing novel diagnostics independently, the company partners with biotechnology and pharmaceutical companies to develop companion diagnostics for use with therapeutic agents.